Overview
The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.
Description
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascendingdose (SAD and MAD) study to evaluate the safety, tolerability, PK, and PD of different doses of HS-10390 tablet(s) in healthy subjects. During the SAD and MAD periods, there will be approximately 6and 3 sequential cohorts respectively. A sentinel dosing strategy will be used in the first cohort ofSAD. The MAD study will start after sufficient safety and PK data of SAD period are obtained.
Eligibility
Inclusion Criteria:
- Healthy male or female subjects between the ages of 18-45 years
- Have no reproductive potential; or agree to use a highly effective method ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing
- Have signed the informed consent form approved by the IRB
Exclusion Criteria:
- History or evidence of clinically significant cardiovascular, pulmonary, endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especiallythose conditions that interfere with absorption, metabolism and/or excretion of the studydrug, determined by the investigator
- Have a clinically significant infection currently or within past 30 days, or have a history ofactive tuberculosis; or have positive screening test for infectious disease, includingtuberculosis, viral hepatitis, AIDS and syphilis
- Have a history of or current allergic disease
- Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol ordrugs of abuse
- Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test resultfor nicotine
- Clinically significant abnormal physical examination, vital signs, clinical laboratory values,ECGs or imaging tests
- Pregnant or breastfeeding female subjects